Dynamic bioabsorbable fastener for use in wound closure

ABSTRACT

A fastener for insertion into pierced openings of a tissue wound has a body formed of a generally bioabsorbable polymer defining an initial capture area. The body includes a pair of arms, each with an inwardly projecting cleat operably joined at an elbow portion defining an internal elbow angle. The arms are operably joined to a backspan at a shoulder portion defining an internal shoulder angle. A durable tissue retention zone is defined between the cleat and the arm. The elbow portion and the internal elbow angle define an insertion width greater than a width of the pierced openings resulting in the pierced openings stretching over the cleat and being elastically retained within the durable tissue retention zone. The fastener captures wound tissue in the initial capture area and then dynamically reforms in response to lateral stresses without a fracture failure of the fastener until a minimum degradation period.

RELATED APPLICATIONS AND PRIORITY CLAIM

The present application is a continuation application of U.S. patentapplication Ser. No. 10/603,397, filed Jun. 25, 2003, now allowed asU.S. Pat. No. 7,112,214, entitled “DYNAMIC BIOABSORBABLE FASTENER FORUSE IN WOUND CLOSURE,” which is a Continuation-In-Part of U.S. patentapplication Ser. No. 10/179,628, filed Jun. 25, 2002, now allowed asU.S. Pat. No. 6,726,705, entitled, “MECHANICAL METHOD AND APPARATUS FORBILATERAL TISSUE FASTENING,” and U.S. Divisional application Ser. No.10/448,838, filed May 30, 2003, now allowed as U.S. Pat. No. 7,686,200,entitled “MECHANICAL METHOD AND APPARATUS FOR BILATERAL TISSUEFASTENING,” all of which are herein incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates generally to the field of surgicalfasteners for use in wound closure. More particularly, the presentinvention relates to a design for a dynamic, bioabsorbable fastenerdesigned for through-and-through insertion across a wound having acapacity to reform when exposed to wound stresses greater than theinitial static strength of the fastener while continuously retaining andapproximating opposing sides of a wound during the healing process.

BACKGROUND OF THE INVENTION

When an opening in tissue is created either through an intentionalincision or an accidental wound or laceration, biological healing of theopening commences through the proximity of the opposed living tissuesurfaces. If the opening is very large or if its location subjects thewound to continual movement, a physician will seek to forcibly hold thesides of the opening together so as to promote the healing process.

In the case of skin tissue, for example, healing occurs best when theopposing dermal layers of the skin tissue are held in tight, primaryproximity with each other. Human skin tissue is comprised of threedistinct layers of tissue. The epidermal layer, also known as theepidermis, is the outermost layer and includes non-living tissue cells.The dermal layer, or dermis, is the middle layer directly below theepidermal layer and comprises the living tissue of the skin that is thestrongest of the three layers. The subcutaneous, or hypodermis layer, isthe bottom layer of skin tissue and includes less connective tissue,making this the weakest layer of skin tissue.

The most prevalent method for forcibly closing a tissue opening isthrough the use of a suture or “stitches.” As early as the secondcentury, the Greeks were using sutures to physically close skinopenings. In its simplest form, a suture is simply a length of materialthat is attached to a tissue-piercing device, such as a needle, andlooped through the opposing sides of a tissue opening. The suture isthen pulled tight and the loop closes, causing the opposing sides of thetissue opening to come into close physical contact. The suture loop isheld tight by the tying of a knot, or knots, or some other lockingmechanism. The first sutures were made of animal gut. Eventually othernatural suture materials including leather, horsehair, flax, cotton andsilk came into use. As the sciences of medical and materials technologyhave advanced over the course of the past century, new bioabsorbablematerials have been developed to further improve upon the basic suturingconcept.

While traditional suturing remains a popular method of effectuatingclosure of skin openings, the use of fasteners, for example staples andstaplers, as a skin closure technique has become increasingly popular,especially in surgical settings where the opening is created through apurposeful incision. In these settings, the incision tends to make aclean, straight cut with the opposing sides of the incision havingconsistent and non-jagged surfaces. Typically, stapling of a skinopening, for example, is accomplished by manually approximating theopposing sides of the skin opening and then positioning the stapler sothat a staple will span the opening. The stapler is then manipulatedsuch that the staple is driven into the skin with one leg being driveninto each side of the skin opening and the cross-member of the stapletraversing the skin opening. Generally, the staple is made of adeformable material such as surgical stainless steel and the legs of thestaple are driven into an anvil causing the staple to deform so as toretain the skin tissue in a compressed manner within the staple. Thisprocess can be repeated along the length of the opening such that theentire incision is held closed during the healing process.

The earliest medical staple designs were manufactured of metal anddesigned to deform around the captured tissue. Examples of these staplesinclude U.S. Pat. Nos. 2,684,070, 3,273,562 and 4,485,816. Althougheffective, metal staples suffer from the drawback of requiringpost-operative removal. As the science of medical polymers developed,staple designs incorporating bioabsorbable materials became available.The use of these bioabsorbable materials eliminated the need forpost-operative removal of the staples. Examples of these staples includeU.S. Pat. Nos. 3,757,629, 4,317,451, 4,741,337, 4,839,130 and 4,950,258.Due to the nature of bioabsorbable polymers; however, bioabsorbablestaples could not be inserted with the same deformation approach used bymetal staples. In fact, bioabsorbable staples were purposefully designedto avoid any deformation requirement, as deformation was seen as apotential failure mechanism. An example of such a design is illustratedby the inwardly biased skin fastener of U.S. Pat. No. 5,089,009. Thus,as the physical and chemical properties of bioabsorbable surgicalstaples evolved, the development of designs and insertion methodsassociated with bioabsorbable staples have focused on avoidingdeformation of the bioabsorbable fastener.

One potential use for bioabsorbable fasteners is in the subcuticularapplication of such fasteners for use in closing skin wounds as shown,for example in a series of patents to Green et al. in U.S. Pat. Nos.5,292,326, 5,389,102, 5,423,856, 5,489,287 and 5,573,541. These patentsdisclose the use of a bioabsorbable, rod-like fastener inserted in asubcuticular manner to assist the healing process. Another bioabsorbablefastener design contemplated for subcuticular wound closure is U.S. Pat.No. 5,618,311 to Gryskiewicz, in which a more traditional staple designis promoted.

If they could effectively retain tissue, the bioabsorbable staples ofthese designs would have many advantages over conventional metalstaples, such as no visible scarring and no need for subsequent removalby a physician. Unfortunately, none of the designs for bioabsorbablestaples to date has been incorporated into a medically or commerciallyefficacious fastener. It would be desirable to provide a bioabsorbablefastener for use in wound closure that could achieve the advantages of abioabsorbable material and still provide for an efficacious woundclosure.

SUMMARY OF THE INVENTION

The present invention is a bioabsorbable fastener for insertion intopierced openings on opposed sides of a tissue wound. A fastener body isformed of a generally bioabsorbable polymer material and defines aninitial tissue capture zone internal to the fastener body. The fastenerbody includes a pair of fastener arms, a cleat operably joined to eachfastener arm at an elbow portion and a backspan operably joined to eachfastener arm at a shoulder portion. Each fastener arm is insertable intoone of the pierced openings. Each cleat projects backward into theinitial tissue capture zone with an internal elbow angle defined betweenthe cleat and the fastener arm. A durable tissue retention zone of eachfastener arm is defined between the cleat and the fastener arm. Eachfastener arm has a maximum insertion width defined between outermostsurfaces of the cleat and the fastener arm. Corresponding internalshoulder angles are defined between the backspan and each fastener armand an internal midspan angle is defined between a midpoint of thebackspan and the apex of each durable tissue retention zone.

The elbow portion and the internal elbow angle of each fastener arm areconstructed with the maximum insertion width being greater than a widthof the corresponding pierced opening such that at least a portion of thetissue surrounding the pierced opening is stretched over the cleat andelastically retained in the durable tissue retention zone for longerthan a minimum degradation period of the bioabsorbable polymer material.The shoulder portions and the internal shoulder angles are constructedso as to capture wound tissue within the initial tissue capture zoneduring deployment of the fastener and then dynamically reform inresponse to lateral stresses applied by the wound tissue afterdeployment such that a sum of the internal elbow angles and the internalmidspan angle remains less than 360 degrees without a fracture failureof the bioabsorbable polymer material until the minimum degradationperiod of the bioabsorbable polymer material.

While the use of bioabsorbable materials for a tissue fastener offersmany advantages, the present invention is the first to recognize thatthe effective use of bioabsorbable materials in the design of a surgicalfastener must both understand and overcome a number of issues related tothe nature of bioabsorbable materials and human tissue, as well as thedynamic process of tissue healing.

First, the thermoplastic polymers used in typical bioabsorbable staplespossess a viscoelastic quality or polymer creep when subjected tocontinuous stress loading due to the nature of their molecular levelbonding and entanglements. Traditionally, bioabsorbable fastener designshave compensated for this creep by either thickening the backspans orstaple legs to prevent or reduce the deformation of the staple, oradding retaining clips or latches to preclude such deformation. Insteadof trying to counteract the viscoelastic qualities of the polymer, thepresent invention takes advantage of these properties to provide for adynamic response to lateral tissue forces that can deform the fastener,but not so far that the cleats of the fastener would release the tissuein the durable tissue retention zone.

Second, if tissue is being retained as opposed to skewered, largeamounts of subcuticular tissue must be retained by the fastener becausesubcuticular tissue tends to be elastic. Grabbing smaller volumes oftissue with a fastener might not ensure that the tissue will beapproximated to achieve an efficacious closure. The fastener of thepresent invention accommodates this requirement without the need for anexcessively large or excessively strong fastener. The fastener of thepresent invention utilizes two different types of tissue capture zones,a first larger initial tissue capture zone that can capture a sufficientamount of tissue when the fastener is deployed to counteract the initialelasticity of the tissue and still obtain an efficacious fastening. Asecond set of much smaller durable tissue retention zones within thecleats are then used to provide long term holding force while the mainbody of the fastener can dynamically reform in response to the lateralforces exerted by the tissue during the healing process.

Finally, when fastening opposing sides of a wound, the opposing sidesmust be physically approximated during placement of the fastener. Oncethe opposing sides have been retainably fastened, the opposing sidestend to return to a more relaxed disposition during the healing process,thereby increasing lateral pressure on the bioabsorbable fastener. Inconventional practice, the bioabsorbable fastener ends up beingover-designed in order to assist in the initial approximation of thetissue that can result in a design that is more susceptible to failureas a result of the longer term lateral pressures applied during thewound healing process. In contrast, the bioabsorbable fastener of thepresent invention is designed for use with an insertion apparatus thatmechanically approximates the opposing sides of wound tissue to insurethe creation of consistent and repeatable pierced openings into whichthe fastener is positioned in a through-and-through manner to takeadvantage of elastically securing the tissue within the durable tissueretention zones created by the cleats of the fastener.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a fastener of the present invention;

FIG. 2 is a side view of the fastener of FIG. 1;

FIG. 3 is a perspective view of the fastener of FIG. 1;

FIG. 4 is a top view of a fastener arm of the fastener of FIG. 1;

FIG. 5 is a top view of the fastener of FIG. 1;

FIG. 6 is a perspective view of a skin wound;

FIG. 7 is a sectional view of the skin wound of FIG. 6;

FIG. 8 is a top view of a delivery device used in closing the skin woundof FIG. 6;

FIG. 9 is a top view of a delivery device including the fastener of FIG.1;

FIG. 10 is a perspective view of a piercing member;

FIG. 11 is a perspective view of an embodiment of a delivery device;

FIG. 12 is a sectional view of the skin wound of FIG. 6 in an everteddisposition;

FIG. 13 is a perspective view of an applicator head including thefastener of FIG. 1;

FIG. 14 is a perspective view of a fastener tip and cleat;

FIG. 15 is a section view of the everted skin wound of FIG. 12 includingthe fastener of FIG. 1 positioned within a pair of target tissue zones;

FIG. 16 is a section of the everted skin wound of FIG. 12 including aplurality of the fasteners of FIG. 1;

FIG. 17 is a top view of the fastener of FIG. 1 positioned within theskin wound of FIG. 6;

FIG. 18 is a top view of lateral forces presented along a fastener armand cleat;

FIG. 19 is a top view of the fastener of FIG. 1 in a semi-opendisposition;

FIG. 20 is a top view of the fastener of FIG. 1 in a generally opendisposition;

FIG. 21 is a top view of the fastener of FIG. 20 within the skin woundof FIG. 6;

FIG. 22 is a perspective view of a plurality of the fasteners of FIG. 20within the skin wound of FIG. 6;

FIG. 23 is a top view of an embodiment of a fastener;

FIG. 24 is a top view of an embodiment of a fastener;

FIG. 25 is a top view of an embodiment of a fastener;

FIG. 26 is a perspective view of an embodiment of a fastener;

FIG. 27 is a perspective view of an embodiment of a fastener beingextruded;

FIG. 28 is a perspective view of an embodiment of a fastener beingstamped;

FIG. 29 is a perspective view of an embodiment of a fastener;

FIG. 30 is a perspective view of an embodiment of a fastener;

FIG. 31 is a top view of the fastener of FIG. 30; and

FIG. 32 is a top view of the fastener of FIG. 30.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Depicted in FIGS. 1-3 is a preferred embodiment of a dynamic,bioabsorbable fastener 100 of the present invention. Generally, fastener100 comprises a pair of arms 102, 104 being operably connected with acommon backspan 106 at shoulder portions 103 and 105, also depicted inFIG. 5, respectively. Arms 102, 104 each preferably include a roundedtip 108, 110. Fastener 100 is further defined by an arcuate exterior,perimeter surface 112 and an arcuate interior surface 114. The arcuateshape of interior surface 114 functions to even out and focus stapleloading forces and reduces potential rocking of fastener 100 when inplace within tissue. Most typically, fastener 100 has a generallycircular cross-section taken through backspan 106 that gradually tapersto a more rectangular cross-section. In order to facilitate moldremoval, fastener 100 can include a plurality of distinct segments andsurfaces as shown for example in FIGS. 3 and 29.

Depending from each of tips 108, 110 at an elbow region 115, 117 is arounded cleat 116, 118. As is more clearly depicted in FIG. 4, cleats116, 118 are defined by an outwardly facing cleat surface 122, aninwardly facing cleat surface 124 and a rounded cleat tip 126. Inwardlyfacing cleat surface 124 connects to interior surface 114 at a cleatbase 128 defining a durable tissue retention zone 129. In combination,interior surface 114 along arms 102, 104 and backspan 106 along with theinwardly facing cleat surfaces 124 define an initial tissue capture zone130.

Design elements of fastener 100 are further depicted in FIG. 5. Thesedesign elements include an effective arm center line 132, an effectivebackspan center line 134, and an effective cleat center line 136. Withregard to effective arm center line 132, effective backspan center line134 and effective cleat center line 136, the center lines generallyrefer to a line relatively equidistant between perimeter surface 112 andinterior surface 114 or a line relatively equidistant between outwardlyfacing cleat surface 122 and inwardly facing cleat surface 124. Due tothe arcuate nature of fastener 100, such center lines are only anapproximation. The intersection of effective arm center line 132 andeffective backspan center line 134 creates an internal shoulder angle138 relative to fastener 100. Shoulder regions 103, 105 are defined asthe areas proximate shoulder angles 138. The intersection of effectivearm center line 132 and effective cleat center line 136 creates aninternal elbow angle 142 relative to fastener 100. Elbow regions 115,117 are defined as the area proximate the elbow angles 142. Other designelements include a backspan width 146, an arm width 147, an arm length148, a cleat length 150, a cleat tip length 152, a cleat tip 126 tocleat tip 126 distance 154 and a tip-to-tip distance 156.

For purposes of a description of the present invention, fastener 100 iscomprised of a generally bioabsorbable polymer selected to maintaineffective retention strength for a period of at least 5 to 21 dayswithin the body, and optimally at least 14 days before eventually beingfully absorbed within the human body. Most preferably, bioabsorbablepolymer comprises a blended bioabsorbable copolymer comprised of 63%polylactide and 37% polyglycolide, commonly referred to as PLGA. Whilethe PLGA copolymer is used in a preferred embodiment, otherbioabsorbable polymers such as polylactide, polyglycolide andpolycaprolactone, either individually, in blends or as copolymers,sharing similar traits including absorption traits, injection moldingtraits and polymer creep traits could be used as well. Similar to otherpolymers, the PLGA copolymer used in the preferred embodiment exhibitsviscoelastic properties in which the entangled molecules under stresstend to slide past one another, creating a viscoelastic creep.

Due to the expense of bioresorbable polymer resins, it is preferable toavoid unnecessary waste during the molding process. In order to reducewaste, fastener 100 is preferably formed using a micromolding injectionmolding process. Micromolding injection molding is typically used whenthe molding shot size is less than 1 gram. Using an appropriatemicromolding injection system, for example a Battenfeld Microsystem M50,resin waste can be significantly reduced during production of a fastener100 in accordance with the present invention. In addition, amicromolding injection system has other processing advantages such asallowing high injection speeds to promote dimensional stability, lowresidence times at elevated temperatures and integrated part handlingcapabilities.

For purposes of maintaining wound closure during the healing process,fastener 100 is designed to supply a minimum dry initial closurestrength of greater than 1.2 lb_(f) per centimeter of wound length. In apreferred embodiment used in subcuticular wound closure, the dry initialclosure strength correlates to a minimum fastener strength of 1.2 lb_(f)per fastener 100 measured laterally between the durable tissue retentionzones 129. One way to achieve a dry initial closure strength of 1.2lb_(f) per centimeter of wound length is to increase the amount ofbioabsorbable polymer present in fastener 100 as opposed to currentfastener designs. In an embodiment of fastener 100, the additionalpolymer is added proportionally to both the arms 102, 104 and backspan106 to optimize the strength of fastener 100. In this embodiment,proportionally adding polymer eliminates weaknesses in fastener 100, forinstance along the backspan 106, in the shoulder regions 140, in arms102, 104 or in elbow regions 144. Such weaknesses may ultimately lead tofastener 100 failure. In this embodiment of fastener 100, thecombination of the arcuate perimeter surface 112 and the arcuateinterior surface 114, distribute lateral forces supplied by the tissuealong the shoulder regions 103, 105. By proportionally increasingbackspan width 146 and arm width 147, fastener 100 can accommodate theconcentration of lateral forces without suffering a failure. Such adesign optimizes the use of the expensive, bioabsorbable polymer thuseliminating unnecessary waste and expense in meeting the dry initialstrength goals.

A preferred use of fastener 100 is in the subcuticular bilateralfastening of dermal tissue to close a skin wound 158, depicted in FIGS.6 and 7, as well as in U.S. patent application Ser. No. 10/179,628entitled, “Mechanical Method And Apparatus For Bilateral TissueFastening,” and U.S. patent application Ser. No. 10/448,838, which is adivisional application also entitled “Mechanical Method And ApparatusFor Bilateral Tissue Fastening,” both of which are commonly assigned tothe assignee of the present invention and are hereby incorporated byreference in their entirety. Skin wound 158 generally comprises a pairof opposing skin surfaces 160, 162 separated by a gap 164. Gap 164 canbe created through either purposeful means, such as a surgical incision,or accidental means such as an accidental cut. Opposing skin surfaces160, 162 each comprise three distinct layers: an epidermal layer, orepidermis 166; a dermal layer, or dermis 168; and a subcuticular layer170. The epidermis 166 comprises dead skin tissue that may hinder butdoes not assist in the biological healing process. The subcuticularlayer 170 comprises a layer of fatty tissue typically lacking thestrength necessary to anchor and hold skin closure fasteners throughoutthe biological healing process. Generally, a physician closes skin wound158 by forcibly approximating the dermis 168 of opposing skin surfaces160, 162. As the dermis 168 comprises living tissue, biological healingof skin wound 158 commences immediately upon approximation and limitedhealing occurs within the first 24 hours of approximation. In addition,the dermis 168 possesses enough strength and elasticity to anchor, holdand retain fastener 100.

Generally as depicted in FIGS. 8, 9, 10 and 11, a delivery device 172incorporating a pair of piercing members 174, 176 is used to introducefastener 100 into wound 158. Most typically, delivery device 172includes a handle 177 and trigger assembly 178 attached to an applicatorhead 180 for advancing and retracting the piercing members 174, 176.Piercing members 174, 176 include a sharp tip 182 for piercing tissue aswell as a semi-circular cross-section 184 defining a retaining space 186that interfaces with and transports fastener 100 into wound 158.Cross-section 184 defines a maximum piercing width 188. Piercing members174, 176 are connected with a backspan member 190. Applicator head 180can also include a guide member 192, a pair of capture zones 194, 196, apair of compression members 198, 200 and a pair of bores 202, 204.

In a preferred use of fastener 100, subcuticular bilateral fastening ofdermal tissue present in wound 158 is accomplished using athrough-and-through bilateral tissue fastening technique described inU.S. patent application Ser. No. 10/607,497, filed Jun. 25, 2003,entitled “Mechanical Method And Apparatus For Bilateral TissueFastening,” which is commonly assigned to the assignee of the presentinvention, the disclosure of which is hereby incorporated by referencein its entirety. In this bilateral tissue fastening technique as shown,for example, in FIG. 8, fastener 100 is loaded between piercing members174, 176 and backspan member 190. Cross-section 184 is designed tosnugly accommodate exterior surface 112 such that only cleats 116, 118protrude inwardly from cross-section 184. Once fastener 100 has beenloaded, guide member 192 is positioned within skin wound 158.Compression members 198, 200 are used to approximate opposing skinsurfaces 160, 162 and force them within capture zones 194, 196.Compression members 198, 200 force skin wound 158 into an everteddisposition 206 shown in FIG. 12. As will be apparent, delivery device172 is capable of a variety of alternative embodiments including varyingorientations of guide member 192, the incorporation of compressionmembers 198, 200 into delivery device 172 and designs in which deliverydevice 172 includes storage and loading means allowing for a multi-shotdesign.

Through precise dimensioning of capture zones 194, 196, a pair of targettissue zones 208, 210 defined in the dermis 168 of opposing skinsurfaces 160, 162 are presented to tips 182 of piercing members 174, 176as depicted in FIG. 15. Using trigger assembly 178, piercing members174, 176 are advanced forward into capture zones 194, 196 andcorrespondingly through the target tissue zones 208, 210 resulting inopenings being pierced in dermal layer 168. Tips 182 continue to advanceout of the target tissue zones 208, 210 and into the bores 202, 204present in guide member 192 as shown in FIG. 13. As piercing members174, 176 advance, fastener 100 is simultaneously advanced into targettissue zones 208, 210. As shown in FIG. 14, the outwardly facing cleatsurface 122 of cleat 116, and similarly cleat 118, define a maximuminsertion width 212 that is purposely designed and manufactured to begreater than the maximum piercing width 188 of piercing members 174,176. Consequently, the openings pierced in the dermis 168 by tips 182 ofpiercing members 174, 176 must stretch to accommodate maximum insertionwidth 212. As cleats 116, 118 are advanced into bores 202, 204, dermis168 is forced to elastically stretch past the tips 126 of cleats 116,118. Dermis 168 then rebounds and elastically snaps into position aroundcleat bases 128 and into durable tissue retention zone 129.

Using trigger assembly 178, piercing members 174, 176 are sequentiallywithdrawn from bores 202, 204, target tissue zones 208, 210 and capturezones 194, 196. However, fastener 100 remains within target tissue zones208, 210 as cleats 116, 118, durable tissue retention zone 129 andespecially cleat bases 128 cooperate to retain the captured dermis 168,preventing fastener 100 from being withdrawn. Backspan 106 traverses gap164, such that opposing skin surfaces 160, 162, and especially dermis168, are forcibly approximated to promote the biological healingprocess. The through-and-through insertion method is typically repeatedalong the length of skin wound 158 such that a plurality of fasteners100 cooperate to forcibly close skin wound 158 as depicted in FIG. 16.Through the use of multiple fasteners 100, the minimum dry initialclosure strength can be increased beyond the typical 1.2 lb_(f) percentimeter of wound length by reducing the distance between fasteners100 along skin wound 158. Correspondingly, the use of multiple fasteners100 allows fastener 100 to be sized and designed for other wound closureapplications or on differing locations of the body. In the preferredembodiment, fastener 100 is placed within skin wound 158 such that itresides generally parallel to the skin surface.

As depicted in FIG. 17, fastener 100 is shown following insertion intowound 158 via the through-and-through method. Prior to and immediatelyfollowing wound closure, fastener 100 is present in a first disposition212 having initial tissue capture zone 130. When in first disposition212, shoulder angle 138 is slightly greater than 90°, while elbow angle142 is substantially less than 90°, most preferably about 25°. Firstdisposition 212 is representative of fastener 100 at time of insertion,herein referred to as T1. In a preferred embodiment, fastener 100 issymmetrical around a center axis 214 depicted in FIGS. 5 and 17.However, alternative embodiments can include asymmetrical designs, forexample, varying arm lengths 148, cleat lengths 150, backspan widths146, differing shoulder angles 138 and elbow angles 142. Preferably,fastener 100 is positioned such that equal amounts of first opposingside 160 and second opposing side 162 are retained within tissue capturezone 130. Following through-and-through insertion of fastener 100 withinwound 158, fastener 100 is exposed to a series of lateral forces 216 asshown in FIG. 18. Lateral forces 216 act along interior surface 114 fromcleat base 128 to shoulder regions 103, 105 during a period of timeafter initial deployment of fastener 100.

To prevent fastener 100 from failing when exposed to lateral forces 216,fastener 100 is manufactured of a bioabsorbable polymer specificallyselected to have polymeric creep during the healing period. If the sumof lateral forces 216 exceed the minimum dry initial closure strength offastener 100, fastener 100 will immediately begin to reform. Oncefastener 100 is placed within wound 158, the closure strength offastener 100 begins to decrease as the combination of body temperatureand body moisture begins to soften, then degrade the bioabsorbablepolymer used in fastener 100. Even if the sum of lateral forces 216 donot initially exceed the maximum dry initial closure strength offastener 100, degradation of bioabsorbable polymer will typically causefastener 100 to reform at some time T2 subsequent to wound closure.

Depicted in FIG. 19 is fastener 100 in a semi-open disposition 218following exposure to lateral forces 216 greater than the fastenerclosure strength. Preferably, fastener 100 does not reform to semi-opendisposition 218 until a period of time T2 of at least 24 hours frominsertion, though depending upon placement and wound location,reformation may occur immediately upon insertion. As depicted, lateralforces 216 exceeding fastener closure strength induce polymer creepprimarily in both shoulder regions 103, 105 and to a lesser degree inelbow regions 115, 117. However, fastener 100 continues to retain andapproximate the captured tissue due to the continuous retention of theelastic dermis around cleat bases 128 and within durable tissueretention zones 129.

Depicted in FIGS. 20 and 21, is fastener 100 in a generally opendisposition 220 following exposure to lateral forces 216 exceeding thoserequired to reform to semi-open disposition 218. Preferably, fastener100 does not reform to generally open disposition 220 until a period oftime T2 of at least 1 to 14 days and optimally at least 7 days frominsertion, though depending upon placement and wound location,reformation may occur immediately upon insertion. Fastener 100 is againreformed through polymer creep in shoulder regions 103, 105 and elbowregions 115, 117. It should be noted that the closure strength offastener 100 decreases over time due to the breakdown of thebioabsorbable polymer by the human body. As such, lateral forces 216which may not initially be enough to induce reforming of fastener 100,will likely induce at least some degree of fastener reforming at a timesubsequent to placement of fastener 100 in wound 158. In generally opendisposition 220, captured tissue remains approximated during the healingprocess as the elastic dermis continues to be retained within cleatbases 128. In general, cleat bases 128 will continue to retain theelastic dermis until the bioabsorbable polymer is absorbed to a pointwhere failure, such as a fracture of arms 102, 104 or backspan 106occurs or polymeric creep in elbow regions 115, 177 results in elbowangle 142 opening beyond 90° such that the elastic dermis 168 slides offof cleats 128. In generally open disposition 220, shoulder angles 138are increasingly difficult to distinguish and instead, an internalmidspan angle 221 defined by a midpoint of the backspan 106 and the apexof each durable tissue retention zone 129, is created. In the preferredembodiment of subcuticular bilateral fastening of dermal tissue asdepicted in FIG. 22, a pair of fasteners 100 that have reformed togenerally open disposition 220 subsequent to insertion continue toapproximate wound 158. Due to the continuing capture of the dermis 168within cleat bases 128, wound 158 remains closed throughout the healingperiod, typically up to twenty-one (21) days. Throughout the reformationprocess, the sum of elbow angles 142 and the midspan angle remains lessthan 360° allowing fastener 100 to continually retain captured tissuebeyond the minimum degradation period. Following minimum degradationperiod referred to as T3, fastener 100 is increasingly likely to suffera fracture failure of the arms 102, 104, cleats 116, 118 or backspan106.

While a preferred embodiment of fastener 100 and its method of use hasbeen described, a variety of other staple configurations featuring thesame dynamic reforming traits as well as through-and-through insertionmethod can be utilized. For example, FIGS. 23, 24 and 25 depictalternative fastener designs incorporating additional retaining elementsto further assist in wound closure. Depicted in FIG. 23, a fastener 222comprises a backspan 224 and arms 226, 228. Arms 226, 228 include tips230, 232 having a hammerhead orientation 234 including an internal cleat236 and an external recess 238. Internal cleat 236 includes a cleat base240 to similarly capture elastic tissue using the through-and-throughinsertion method. Depicted in FIG. 24, a fastener 242 comprises abackspan 244 and arms 246, 248. Arms 246, 248 include tips 250, 252include an internal cleat 254 to similarly capture elastic tissue usingthe through-and-through method. In addition, arms 246, 248 include aseries of internal projections 256 to further assist in retainingcaptured tissue as fastener 242 reforms in response to lateral forcessupplied by captured tissue. Depicted in FIG. 25, a fastener 258comprises a backspan 260 and arms 262, 264. Arms 262, 264 include tips266, 268 having an internal cleat 270 to similarly capture elastictissue using the through-and-through method. In addition, backspan 260includes a pair of opposed projections 272, 274 to further assist inretaining captured tissue as fastener 258 reforms in response to lateralforces supplied by captured tissue. Although the fasteners of thepresent invention have been described with respect to an initial tissuecapture zone that is defined by just two arms and within a single plane,it will be seen that a multiplicity of arms could be provided and thatmultiple planes could be accommodated for the tissue capture zone by,for example, making an angle in the backspan at the midpoint.

Depicted in FIG. 26 is another embodiment of a fastener of the presentinvention. A fastener 276 can comprise any of the alternative fastenerconfigurations but in a design using at least two distinct bioabsorbablelayers. As depicted, fastener 276 includes a first bioabsorbable layer278, a second bioabsorbable layer 280 and a third bioabsorbable layer282. While this embodiment depicts a planar arrangement of differentbioabsorbable materials, it will be recognized that multiple injectionpoints along a mold could also be used to accomplish a similarconstruction with different polymer materials being present at theshoulder and elbow regions, for example. In practice, fastener 276 canbe formed by adhesive, thermal or molding processes where the layers arebonded after being separately manufactured using the previouslydescribed micromolding process or alternatively, through an extrusionprocess 284 as shown in FIG. 27. In yet another alternativemanufacturing process, fastener 276 can be stamped or cut from a sheet286 comprising a plurality of bioabsorbable layers 288 as shown in FIG.28. Fastener 276 having multiple bioabsorbable layers 288 has a numberof design advantages including the ability to mix and match fasterdegrading bioabsorbable polymers with slower degrading bioabsorbablepolymers. In addition, fastener 276 could be used as a deliveryinstrument by incorporating drugs or medicants, such as antibiotics,clotting agents, or even gene therapy between layers or zones to providea time release as the layers are broken down within the body, or evenonto the exterior surfaces of the fastener to facilitate the healingprocess.

Depicted in FIG. 29 is another alternative embodiment of a fastener 290.Fastener 290 comprises a backspan 292 and arms 294, 296. Fastener 290included a thickness 297 that is generally consistent through backspan292 and arms 294, 296. Arms 294, 296 further include tips 298, 300, eachtip 298, 300 having an internal cleat 302 having a cleat base 304. Arms294, 296 in combination with internal cleat 302 and cleat base 304define a durable tissue retention zone 306 to capture elastic tissueusing the through-and-through insertion method as previously described.

In FIGS. 30 and 31, there is shown an earlier embodiment of a fastener400 of the present invention. Fastener 400 has body portion 402, whichcomprises a cross-member 408 connecting a pair of fork members or legs406. The outer margins 410 of each leg 406 are dimensioned and shapedaccommodatingly to the retaining space 186 of piercing members 174, 176,allowing fastener 400 to fit and slide between the piercing members 174,176. Shoulders 414 preferably are provided to engage the solidcylindrical cross-section of the backspan member 190, thus allowingfastener 400 to be advanced distally with motion of the piercing members174, 176. The distal end 412 of each leg 406 is incurvately shaped toallow easier passage through an opening in skin, referred to as a skive,that is created by piercing members 174, 176. Inwardly directed barbs404 preferably are provided on each leg 406 to resist withdrawal of thefastener once emplaced.

Although an overall U-shape for the fastener 400, as shown in FIGS. 30and 31 is preferred, other shapes having a capability for bilateraltissue engagement are also possible and within the scope of theinvention. Such other shapes include for example, but are not limitedto, a square shape similar to an ordinary staple, a semi-circular orC-shape or a V-shape or W-shape, in which the cross-member 408 has bendsor other features. While the shape of fastener 400 is generallydetermined in a planar configuration, it will be recognized that othernon-planar shapes and configurations can be used, such as a fastenerhaving multiple projections for each leg 406, with each projectionoriented in a different plane, or a fastener having cross-member 408arranged in a V-shape projecting out of the normal plane of the fastener400. Two leg members 406 are preferred, but it will be understood thatadditional leg members 406 could be added in the same or a differentplane of the fastener 400 such that the leg members of each side of thefastener form a dident or trident configuration, for example.

As shown in FIG. 32, an inner cross-sectional area 409 is defined by thefastener 400 for capturing the compressed dermal tissue. In a preferredembodiment, inner cross-sectional area 409 ranges from 1.5 sq. mm to 50sq. mm and most preferably about 5 sq. mm to 10 sq. mm. This area isgenerally defined by an inner diameter length of between 1.5 mm and 9 mmand most preferably about 3.8 mm and an inner diameter width of between1 mm and 5 mm and most preferably about 2 mm. It will be apparent thatnumerous shapes and configurations can be used for the shape andarrangement of cross-sectional area 409. Preferably, innercross-sectional area 409 is generally arrowhead shaped as a result ofthe positioning of the barbs 412. As will be described, the barbs 412 orsimilar anti-reversing projections resist against the withdrawal offastener 400. While the barbs 412 are preferably oriented into the innercross-sectional area 409, it will be appreciated that barbs 412 may beomitted or may be oriented outwardly.

Although it is possible for fastener 400 to be deformed during deliveryand application, preferably the majority of dermal tissue retainedwithin cross-sectional area 409 is captured in a compressed state by afastener 400 that is sufficiently rigid so as to retain the dimensionalintegrity of cross-sectional area 409 within +/−30% of its designed areafor a period of preferably at least 10 days. Most preferably, structuralintegrity of fastener 400 is maintained for at least 21 days. In thisway, the dermal tissue captured in fastener 400 is retained in acompressed state for a period sufficient to allow the biological healingprocess to occur without the dermal tissue being under tension duringthe healing process. Preferably, the dimensions of the fastener 400 andthe operation of the applicator assembly 100 coordinate to create acompression ratio of dermal tissue within the inner cross-sectional area409 that is greater than one. The compression ratio is defined either asa ratio of area or a ratio of width. In the case of width, thecompression ratio is the ratio of the dimension defined by the positionof the skive relative to the vertical interface 51 when the dermaltissue is at rest divided by the position of the skive relative to thevertical interface as held by the fastener 400. In the case of area, thecompression ratio is the ratio of the area of dermal tissue that will beretained by the fastener 400 when that dermal tissue is at rest dividedby the actual cross-sectional area 409.

Alternatively, it is possible to take advantage of the bilateral tissuefastening in the tissue target zone as taught by the present inventionwith a deformable fastener where the deforming of a bioresorbable orbioabsorbable fastener serves to provide at least some of thecompression of the dermal tissue such that the need for a mechanicaltissue manipulator is reduced or potentially eliminated. In thisembodiment, a bioresorbable or bioabsorbable fastener would be deformedby the applicator apparatus in order to appropriately compress thedermal tissue. Deformation of a bioresorbable or bioabsorbable fastenercould be accomplished in a number of ways, including prestressing thefastener into an open configuration such that it returns to a closedconfiguration, with or without mechanical assistance from theapplicator, application of ultrasound, heat or light energy to alter theshape of, or reduce or relax stresses in, the fastener in situ,designing a polymer material with appropriate shapes and compositionsthat the material is deformable upon deployment without fracturing, orany combination of these techniques.

Fastener 400 is preferably formed from any suitable biodegradablematerial. The currently most preferred biodegradable material is alactide/glycolide copolymer where the ratio is never less than at least10% of one element and preferably in a range of 60%-70% lactide.Examples of other suitable materials include poly(dl-lactide),poly(l-lactide), polyglycolide, poly(dioxanone),poly(glycolide-co-trimethylene carbonate), poly(l-lactide-co-glycolide),poly(dl-lactide-co-glycolide), poly(l-lactide-co-dl-lactide) andpoly(glycolide-co-trimethylene carbonate-co-dioxanone). In addition,other suitable materials could include compositions with naturallyoccurring biopolymers such as collagen and elastin, or stainless steel,metal, nylon or any other biocompatible materials in the case of anon-absorbable fastener, or even various combinations of such materialsdepending upon the desired application and performance of the fastener.

While a preferred embodiment of a dynamic, bioabsorbable fastener of thepresent invention has been described, it will be apparent to one skilledin the art that a fastener in accordance with the present invention iscapable of numerous other embodiments without departing from the scopeand spirit of the present invention.

1. A bioabsorbable fastener for insertion into pierced openings onopposed sides of a tissue wound comprising: a fastener body formed of agenerally bioabsorbable polymer material and defining an initial tissuecapture zone internal to the fastener body, the fastener body including:a pair of fastener arms, each fastener arm insertable into one of thepierced openings; a cleat operably joined to each fastener arm at anelbow portion and projecting backward into the initial tissue capturezone with an internal elbow angle defined between the cleat and thefastener arm of less than 90 degrees; a durable tissue retention zone ofeach fastener arm defined between an inwardly facing surface of thecleat and an interior surface along the fastener arm and having an apexat the elbow portion; a maximum insertion width of each fastener armdefined between outermost surfaces of the cleat and the fastener arm;and a backspan operably joined to each fastener arm at a shoulderportion with corresponding internal shoulder angles defined between thebackspan and each fastener arm and an internal midspan angle definedbetween a midpoint of the backspan and the apex of each durable tissueretention zone, wherein the elbow portion and the internal elbow angleof each fastener arm are constructed with the maximum insertion widthbeing greater than a width of the corresponding pierced opening suchthat at least a portion of the tissue surrounding the pierced opening isstretched over the cleat and elastically retained in the durable tissueretention zone for longer than a minimum degradation period of thebioabsorbable polymer material, and wherein the shoulder portions andthe internal shoulder angles are constructed so as to capture woundtissue within the initial tissue capture zone during deployment of thefastener in a first insertion disposition and then dynamically reform toa second generally open disposition in response to lateral stressesapplied by the wound tissue after deployment such that the internalmidspan angle is at least two times greater when measured in the secondgenerally open disposition as compared to the first insertiondisposition and wherein the internal midspan angle remains less than180° in the second generally open disposition.
 2. The fastener of claim1, wherein the initial tissue capture zone is defined by a generallyplanar cross-section defined by a coplanar orientation of a centerlineof each of the pair of fastener arms and the backspan.
 3. The fastenerof claim 1, wherein the minimum degradation period of the bioabsorbablepolymer material is between five to twenty-one days.
 4. The fastener ofclaim 1, wherein the shoulder portions and the internal shoulder anglesare constructed so as to generally maintain a shape of the initialtissue capture zone during deployment of the fastener and notdynamically reform in response to lateral stresses applied by the woundtissue after deployment for an initial period of time less than theminimum degradation period.
 5. The fastener of claim 1, wherein theinitial period of time is between one to fourteen days.
 6. The fastenerof claim 1, wherein the internal elbow angles are constructed in a rangebetween 15-70 degrees and the internal shoulder angles are constructedin a range between 70 and 110 degrees.
 7. The fastener of claim 1,wherein the internal elbow angles are less than the internal shoulderangles.
 8. The staple of claim 1, wherein the staple arm and thebackspan generally define an interior shoulder angle, the interiorshoulder angle dynamically transitions from between 70°-100° in thefirst inserted position to between 120°-180° in the second deformedposition.
 9. A dynamic bioabsorbable staple for use with a wound inliving tissue having opposed sides, the staple comprising: a staple bodyformed of a generally bioabsorbable polymer, the staple body including:a pair of staple arms each having a distal end and a proximal shoulderportion; a backspan joining the pair of staple arms proximate theshoulder portions; each shoulder portion being constructed so as todeform without failing in response to lateral forces naturally exertedby the opposed sides of the wound from a first inserted position to asecond deformed position; each staple arm having a cleat definedproximate the distal end of the staple arm that is operably angledtoward the backspan and defines a tissue retention zone between aninwardly facing surface of the cleat and an inwardly facing surface ofthe staple arm that defines an internal elbow angle of less than 90degrees such that the tissue retention zone effectively retains tissuewhen the staple arm is both in the first inserted position and in thesecond deformed position; and wherein an internal midspan angle isdefined between a midpoint of the backspan and an apex of each tissueretention zone internal midspan angle such that the internal midspanangle is at least two times greater when measured in the second deformedposition as compared to the first insertion position and wherein theinternal midspan angle remains less than 180° in the second deformedposition.
 10. A bioabsorbable, subcutaneous staple comprising: a staplebody formed of a generally bioabsorbable polymer, the staple bodyincluding: a pair of staple arms each having a distal end and a proximalshoulder portion, the distal end including an inwardly directed cleat,each cleat and arm defining an elbow portion between an inwardly facingcleat surface and an interior arm surface, the elbow portion having aninternal elbow angle of less than 90 degrees; and a backspan joining thepair of staple arms proximate the shoulder portions, wherein the cleats,arms and backspan cooperatively define a dynamic internal tissue capturezone, the internal capture zone presenting a first shape at an insertiontime, the elbow portions and shoulder portions dynamically transitioningin response to lateral forces applied by opposing sides of a tissuewound without failure such that the internal capture zone presents asecond shape at a second time subsequent to the insertion time and priorto a minimum degradation period of the bioabsorbable polymer, wherein aninternal midspan angle is defined between a midpoint of the backspan andan apex of each elbow portion such that the internal midspan angle is atleast two times greater when measured in the second shape as compared tothe first shape and wherein the internal midspan angle remains less than180° in the second shape.
 11. The bioabsorbable, subcutaneous staple ofclaim 10, wherein the arms and backspan define an interior surfaceadjacent the internal capture zone and wherein the interior surfacecomprises at least one retaining element projecting into the internalcapture zone.
 12. The bioabsorbable, subcutaneous staple of claim 10,wherein the arms and backspan define an exterior surface and wherein theexterior surface comprises at least one retaining element.
 13. Thebioabsorbable, subcutaneous staple of claim 12, wherein the retainingelement is selected from the group comprising: a projecting member or anexternal recess.
 14. The bioabsorbable, subcutaneous staple of claim 10,wherein the internal capture zone defines a tissue capture area whereinthe tissue capture area is with a range from about 1.5 squaremillimeters to about 50 square millimeters.
 15. The bioabsorbable,subcutaneous staple of claim 10, wherein the bioabsorbable polymer isselected from the group comprising: a lactide/glycolide copolymer, apoly(dl-lactide), a poly(l-lactide), a polyglycolide, a poly(dioxanone),a poly(glycolide-co-trimethylene carbonate), apoly(l-lactide-co-glycolide), a poly(dl-lactide-co-glycolide), apoly(l-lactide-co-dl-lactide), a poly(glycolide-co-trimethylenecarbonate-co-dioxanone), collagen and elastin.
 16. The bioabsorbable,subcutaneous staple of claim 10, wherein the backspan and the armsdefine a generally planar staple configuration.